First National Donation Congress For Clinical Leads …...Research Ethics Committees National Bodies...

25
First National Donation Congress For Clinical Leads and Donation Committee Chairs

Transcript of First National Donation Congress For Clinical Leads …...Research Ethics Committees National Bodies...

Page 1: First National Donation Congress For Clinical Leads …...Research Ethics Committees National Bodies associated with ODT UKDECsTWO GUIDING PRINCIPLES 1The offer of organ donation should

First National Donation CongressFor Clinical Leads and Donation

Committee Chairs

Page 2: First National Donation Congress For Clinical Leads …...Research Ethics Committees National Bodies associated with ODT UKDECsTWO GUIDING PRINCIPLES 1The offer of organ donation should

Removing the obstacles, both real and perceived, to successful organ donation and transplantation

Page 3: First National Donation Congress For Clinical Leads …...Research Ethics Committees National Bodies associated with ODT UKDECsTWO GUIDING PRINCIPLES 1The offer of organ donation should
Page 4: First National Donation Congress For Clinical Leads …...Research Ethics Committees National Bodies associated with ODT UKDECsTWO GUIDING PRINCIPLES 1The offer of organ donation should

Healthcare ProfessionalsIntensivists, CLODs, Surgeons, Physicians

Nurses in ICU, Theatres, Emergency Departments, SN-ODs

Donors and their families

Recipients and their families

Local Donation Ethics Committees

Research Ethics Committees

National Bodies associated with ODT

Page 5: First National Donation Congress For Clinical Leads …...Research Ethics Committees National Bodies associated with ODT UKDECsTWO GUIDING PRINCIPLES 1The offer of organ donation should

UKDEC s TWO GUIDING PRINCIPLES

1 The offer of organ donation should be a routine part of planning end of life care 2 Once it has been agreed that organ donation is in the patient s best interests, the ethical imperative is to enable the most successful outcome to that donation

Page 6: First National Donation Congress For Clinical Leads …...Research Ethics Committees National Bodies associated with ODT UKDECsTWO GUIDING PRINCIPLES 1The offer of organ donation should

PART 1 ETHICAL FRAMEWORK

**Definition, diagnosis and confirmation of death

Exploring a competent individual s views about organ donation.

Deciding that continuation of life-sustaining treatment is no longer of overall benefit.

Determining whether organ donation is of overall benefit to an incompetent patient

**Conflicts of interest

Page 7: First National Donation Congress For Clinical Leads …...Research Ethics Committees National Bodies associated with ODT UKDECsTWO GUIDING PRINCIPLES 1The offer of organ donation should

ISSUES SURROUNDING THE DIAGNOSIS AND CONFIRMATION OF DEATH

Death is the irreversible loss of the capacity for consciousness combined with the irreversible loss of the capacity to breathe, both of which are functions of the brain-stem and are lost rapidly after cardiac arrest

Diagnosis should be independent of any consideration of organ donation

Brain death diagnosis by neurological criteria using the Academy Code of Practice is the accepted standard in the UK

Page 8: First National Donation Congress For Clinical Leads …...Research Ethics Committees National Bodies associated with ODT UKDECsTWO GUIDING PRINCIPLES 1The offer of organ donation should

DIAGNOSIS OF DEATH USING CARDIO-RESPIRATORY CRITERIA

Cardio-respiratory diagnosis as normally practiced does not need to be made quickly

Cardio-respiratory criteria are valid since they infer that the integrative and consciousness aspects of brain function will inevitably be lost over time

Cardio-respiratory diagnosis linked to ODT introduces a critical time issue

Time critical for organ viability and to minimise warm ischaemia time

Page 9: First National Donation Congress For Clinical Leads …...Research Ethics Committees National Bodies associated with ODT UKDECsTWO GUIDING PRINCIPLES 1The offer of organ donation should

In DBD, brain death criteria use specific tests to confirm that the integrative and consciousness aspects of brain function have been lost

In DCD, cardio-respiratory criteria are valid since they infer that the integrative and consciousness aspects of brain function will inevitably be lost provided that certain pre-requisites are fulfilled

In DCD, the 5 minute rule refers to the period beyond which auto-resuscitation will not occur

Hence the pressure for shortening this interval

Page 10: First National Donation Congress For Clinical Leads …...Research Ethics Committees National Bodies associated with ODT UKDECsTWO GUIDING PRINCIPLES 1The offer of organ donation should

VALIDITY OF CARDIO-RESPIRATORY CRITERIA

The criteria are valid providing:

There is no intention to attempt cardio-pulmonary resuscitation

The possibility for spontaneous resumption of cardiac function (auto-resuscitation) has passed

When reperfusion of organs with oxygenated blood is performed as part of the retrieval process, it should, as far as it practical, be restricted to the relevant organs

Page 11: First National Donation Congress For Clinical Leads …...Research Ethics Committees National Bodies associated with ODT UKDECsTWO GUIDING PRINCIPLES 1The offer of organ donation should

IN ALL SITUATIONS IT IS CRUCIAL THAT, AS STATED IN THE

ACADEMY S CODE OF PRACTICE, DEATH IS DIAGNOSED AND

CONFIRMED BEFORE ORGAN RETRIEVAL CAN COMMENCE

Page 12: First National Donation Congress For Clinical Leads …...Research Ethics Committees National Bodies associated with ODT UKDECsTWO GUIDING PRINCIPLES 1The offer of organ donation should

Recommendation Any clinician involved in the care of the donor should not have a duty of care to the recipient at that time. In particular, members of the retrieval team and the recipient s clinical team should not be involved in the care of the potential donor prior to death being confirmed. There should, however, be effective liaison and communication between the retrieval team and those caring for the potential donor in order to ensure that the interests of the patient as a potential donor are maintained at all times

Page 13: First National Donation Congress For Clinical Leads …...Research Ethics Committees National Bodies associated with ODT UKDECsTWO GUIDING PRINCIPLES 1The offer of organ donation should

DEATH AND SUBSEQUENT INTERVENTIONS CONFLICTS OF INTEREST

Recommendation After death, the potential conflict of interest between saving the life of the patient and respecting their interest to be an organ donor disappears. Once the decision to accept the organs has been taken, it is for the overall benefit of both the deceased patient and the recipient for procedures such as re-intubation to facilitate lung retrieval, to be carried out by suitably trained individual. Thus, although this professional may have been a member of the donor s clinical team prior to death, this no longer represents a conflict of interest.

Page 14: First National Donation Congress For Clinical Leads …...Research Ethics Committees National Bodies associated with ODT UKDECsTWO GUIDING PRINCIPLES 1The offer of organ donation should

5 minobs

patientdying

Timelines and responsibilities

Before death confirmed After death confirmed

WLST

Deathdiagnosed

Note:Any resumption of cardiac activity should prompt recall of the donor clinical team and the diagnosis and confirmation of death protocol should be repeated.

Consent to donate WLSTTimeline

Donor

SN-OD

Donorteam

Retrieval team

Co

nfi

rmat

ion

of

Dea

th

Retrieval commences

patientmaintained

Organs removed

Organs transported

Liaison role between family and donor and recipient teams. Does not provide medical care to the donor

Liaison role continues even if donation doesnot proceed. May now provide medical care to the donorPerforms final act of care

Responsible for care of potential donorand undertake all interventions. Diagnosis and confirmation of death

Hand over to retrieval team.

May re-intubate for lung retrieval.

Responsible for care of donor

Carry out retrieval surgery

Set up for retrieval. Take no part in caring for the potential Donor, but liaise with donor team.

Note:Donor team undertake all interventions, including any intended specifically to maintain organs.

Surgery complete

Page 15: First National Donation Congress For Clinical Leads …...Research Ethics Committees National Bodies associated with ODT UKDECsTWO GUIDING PRINCIPLES 1The offer of organ donation should

PART 2: THE POTENTIAL DONOR PATHWAY

**Deciding further treatment is no longer in a patient s best interests and seeking consent for organ donation

**Management before withdrawal of life sustaining treatment

Suitable criteria for DCD

**Process of withdrawal of life-sustaining treatment

If death does not occur within a time appropriate for donation

Death and subsequent interventions

Page 16: First National Donation Congress For Clinical Leads …...Research Ethics Committees National Bodies associated with ODT UKDECsTWO GUIDING PRINCIPLES 1The offer of organ donation should

DECIDING FURTHER TREATMENT IS NO LONGER OF OVERALL BENEFIT AND SEEKING CONSENT FOR ORGAN

DONATION

Recommendation Two senior doctors, who should both have been registered for at least five years, and at least one of whom should be a consultant, should verify that further active treatment is no longer of overall benefit to the patient.It would be preferable for this to be the case for all patients,not only for those where organ donation is a possibility (although the UKDEC remit extends only to organ donation).

Page 17: First National Donation Congress For Clinical Leads …...Research Ethics Committees National Bodies associated with ODT UKDECsTWO GUIDING PRINCIPLES 1The offer of organ donation should

MANAGEMENT BEFORE WITHDRAWAL OF LIFE-SUSTAINING TREATMENT

Recommendation If organ donation has been identified as part of the end of life care pathway for a patient, then caring for that patient during the dying process in such a way as to maintain the organs in the best possible condition for donation does not represent a conflict of interest on the part of the treating clinician. Because it is considered to be for the overall benefit of the patient to become a donor, interventions to facilitate this are also likely to be of benefit unless they may cause harm or distress or risk causing harm or distress.

Page 18: First National Donation Congress For Clinical Leads …...Research Ethics Committees National Bodies associated with ODT UKDECsTWO GUIDING PRINCIPLES 1The offer of organ donation should

PROCESS OF WITHDRAWAL OF LIFE-SUSTAINING TREATMENT

Recommendation Until national protocols for withdrawal of life-sustaining treatment are available, local protocols need to be agreed within each institution. Organ donation will be one of a number of factors which will have a bearing on the way in which withdrawal of life-sustaining treatment is carried out. Donation Committees have an important role in facilitating their development locally and should forge effective links with End of Life Care strategy teams.

Page 19: First National Donation Congress For Clinical Leads …...Research Ethics Committees National Bodies associated with ODT UKDECsTWO GUIDING PRINCIPLES 1The offer of organ donation should

MANAGEMENT BEFORE WITHDRAWAL OF LIFE-SUSTAINING TREATMENT

Recommendation Interventions to maintain cardio-respiratory stability and critical organ perfusion are appropriate, until such time as withdrawal of life-sustaining treatment (WLST) is instigated.

Page 20: First National Donation Congress For Clinical Leads …...Research Ethics Committees National Bodies associated with ODT UKDECsTWO GUIDING PRINCIPLES 1The offer of organ donation should

Death as diagnosed by cardio-respiratory criteria means that integrated bodily function in terms of consciousness or the capacity to breathe has ceased, rather than that individual organs have died

Thus the filtration activity of the kidney or the metabolic activity of the liver can be restored by the provision of a supply of oxygenated blood

Page 21: First National Donation Congress For Clinical Leads …...Research Ethics Committees National Bodies associated with ODT UKDECsTWO GUIDING PRINCIPLES 1The offer of organ donation should

In the case of circulatory death, the heart stops because its inherent pumping action is inhibited by the build up of acid metabolites, secondary to hypoxia, following cessation of respiration

In this situation, the heart itself has not actually died and reperfusion of the heart, in a variety of ways, with oxygenated blood will restore its pumping action

Thus cardiac function is preserved in a brain dead patient who is still being artificially ventilated

Page 22: First National Donation Congress For Clinical Leads …...Research Ethics Committees National Bodies associated with ODT UKDECsTWO GUIDING PRINCIPLES 1The offer of organ donation should

ORGAN REPERFUSIONRE-ESTABLISHING CARDIAC ACTIVITY

Any in vivo procedure which restores blood flow to the whole body rather than an isolated organ contravenes the provisions under which the 5 minute rule is valid

Recommendation When reperfusion of organs with oxygenated blood is performed as part of the retrieval process, it should, as far as it practical, be restricted to the relevant organs

Page 23: First National Donation Congress For Clinical Leads …...Research Ethics Committees National Bodies associated with ODT UKDECsTWO GUIDING PRINCIPLES 1The offer of organ donation should

ETHICAL / CLINICAL REASONS FOR ISOLATING THE CEREBRAL CIRCULATION

Any procedure that risks restoring circulation throughout the whole body has the potential merely to prolong the final stages of the dying process, and is therefore unethical and not of overall benefit to the patient

The Code of Practice clearly states it is obviously inappropriate to initiate any intervention that has the potential to restore cerebral perfusion after death has been confirmed

Recent evidence suggests that cerebral re-perfusion may also have a detrimental effect on the organs to be donated

Page 24: First National Donation Congress For Clinical Leads …...Research Ethics Committees National Bodies associated with ODT UKDECsTWO GUIDING PRINCIPLES 1The offer of organ donation should

ISSUES WHICH STILL NEED FURTHER RESOLUTION

Could the time interval prior to cardiac donation be shortened, particularly in children?

Pharmacological therapy to improve organ function e.g. inotropes, heparin

Invasive interventions to improve organ function and minimise warm ischaemia time e.g. cold perfusion, ECMO, elective ventilation

For an intervention to be considered, it has to be shown not to cause or risk causing harm or distress to the patient, but the degree of risk versus benefit is undefined.

Page 25: First National Donation Congress For Clinical Leads …...Research Ethics Committees National Bodies associated with ODT UKDECsTWO GUIDING PRINCIPLES 1The offer of organ donation should

Widespread support for ODT in principle

Many faiths actively promote donation in perpetuating the gift of life

While donation normal in UK, those coming from countries where ODT is not available are uncertain over faith teaching

Different interpretations within single faith

Does my faith allow me to donate?

Relatives need reassurance from their faith leader